FDA Accepts sBLA for Self-Administered Intranasal Influenza Vaccine from AstraZeneca

AstraZeneca announced¹ on Tuesday the FDA had accepted its supplemental biologic license application (sBLA) for approval of a self- or caregiver-administered option for the company’s influenza vaccine live, intranasal (Flumist Quadrivalent).

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The vaccine, originally approved in the US in 2003, is indicated for use in appropriate individuals aged 2 through 49 years and if the sBLA is approved, would be the only influenza vaccine available to be self-administered by eligible patients or given by caregivers.¹

The FDA’s Prescription Drug User Fee Act date is expected as soon as the first quarter of 2024, according to the company.

“A self-administered option for Flumist Quadrivalent would leverage the unique attributes of the product, providing a convenient new choice for individuals and families who want to protect their loved ones against flu,” Ravi Jhaveri, MD, division head, Infectious Disease; Virginia H. Rogers professor in infectious diseases, professor of pediatrics, Northwestern University School of Medicine, said in the announcement.¹

Typically, between 3% and 11% of the US population will get infected with the influenza virus each season and children are disproportionately affected, according to the Centers for Disease Control and Prevention.² Children and adolescents aged 5 to 17 years represent nearly 40% of acute respiratory infection medical visits during the season while they make up only 22% of the US population.²

Jhaveri points out that influenza vaccination rates among children and adults younger than age 50 years declined in the 2022-2023 flu season just passed, “highlighting a need for more accessible solutions.”¹

The company aims to have Flumist Quadrivalent available for delivery directly to individual homes, an innovative approach to increasing ease of access for families and their communities, Iskra Reic, AstraZeneca executive vice president, vaccines, and immune therapies, commented in the statement. As the only intranasal flu vaccine available worldwide for more than 20 years, Reic is confident that a self-administered option could “revolutionize” flu vaccination.¹

“The ability…to choose where to administer an injection-free flu vaccine could help increase…vaccination rates, and greatly benefit those most impacted by this serious and contagious respiratory illness,” Jhaveri said.¹

Flumist Quadrivalent is an Advisory Committee on Immunization Practices and American Academy of Pediatrics recommended flu vaccine option.¹

If the vaccine is approved next year, AstraZeneca said it anticipated to be available for self-administration in the US for the 2024/2025 flu season.¹

References

1. US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal). News Release. AstraZeneca. October 24, 2023. Accessed October 25, 2023. https://www.astrazeneca-us.com/media/press-releases/2023/us-food-and-drug-administration-accepts-for-review-astrazenecas-supplemental-biologics-license-application-for-self-administration-of-flumist-quadrivalent-influenza-vaccine-live-intranasal.html
2. 2021–2022 estimated flu illnesses, medical visits, hospitalizations, and deaths prevented by flu vaccination. Centers for Disease Control and Prevention. Updated what. Accessed October 25, 2023. https://www.cdc.gov/flu/about/burden-averted/2021-2022.htm#references